CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
N2O/O2 analgesia +1 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02696460
NCT02696460N/ACompleted

Efficacy of Inhaled 50% Equimolar Nitrous Oxide/Oxygen Gas Premix (Kalinox®) as Compared to Topically Administered 5% Eutectic Mixture of Lidocaine/Prilocaine (EMLA®) in Chronic Leg Ulcer Debridement

Venenklinik Bellevue·interventional·Posted Mar 2, 2016·Updated Mar 2, 2016

In Brief

A clinical study evaluating N2O/O2 analgesia and Lidocaine/Prilocaine analgesia for Chronic Leg Ulcer. Completed, enrolled 21 participants.

Detailed Summary

Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A common analgesia method is the topical administration of local anesthetics directly onto the wound. However, complete wound debridement is often hampered by insufficient analgesia leading to interruption of the actual debridement and fragmentation of treatment into more frequent serial debridement sessions. Alternatively, the inhalation of an nitrous oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the investigators have compared the analgesic method of an eutectic mixture of topically administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50% N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2016
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.3 years ago

Interventions

N2O/O2 analgesiaprocedure

Analgesia for ulcer debridement procedure is provided by the inhalation of N2O/O2 gas premix.

Lidocaine/Prilocaine analgesiaprocedure

Analgesia for ulcer debridement procedure is provided by topically administered lidocaine/prilocaine cream.